Senior Quality Assurance Professional
About the Role:
We are seeking a seasoned Senior Quality Engineer to join our team. Reporting directly to the Senior Quality Manager, this individual will be responsible for ensuring the quality of our medical devices throughout all stages of development, manufacture, and commercialization.
* Collaborate with cross-functional teams to develop and implement quality plans, procedures, and programs
* Provide quality support during in-house manufacture and lot release
* Ensure compliance with regulatory requirements and company policies
* Analyse and report on quality discrepancies related to product design and manufacture
* Liaise with OEM contractors and vendors during component manufacture
* Support regulatory agency audits and prepare non-conformity responses as necessary
Requirements:
To succeed in this role, you will need:
* A bachelor's degree in a relevant engineering or science field
* At least 5 years' experience in the medical device industry or equivalent higher-level postgraduate study
* Strong project planning, communication, and writing skills
* Sound understanding of engineering fundamentals
* Knowledge of medical device quality and regulatory systems, including ISO13485 and FDA CFR 820
* Cleanroom and sterilisation experience preferred
* Process validation experience preferred
Contact Information:
For further information, please contact James Cassidy or call 086 0204322 in confidence.